Uni III
by Rudolf Riester GmbH & Co. KG
510(k) K925753
Uni III is a Class I device made by Rudolf Riester GmbH & Co. KG, cleared under FDA 510(k) K925753 on 8 Oct 1993, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925753 | Date8 Oct 1993 | StatusActive |
Official records
- FDA 510(k) database K925753
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ERA
- Device class
- Class I
- Regulation
- 21 CFR Part 874.4770
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K925753
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| uni® III otoscope/May-ophthalmoscope Vacuum 2.7 V 2030 | 2030 / 2030 | 04045396002753 | — | On the market |
| uni® III otoscope/May-ophthalmoscope XL 2.5 V, 2030-201 | 2030-201 / 2030-201 | 04045396130340 | — | On the market |
| uni® III otoscope/May-ophthalmoscope XL 3.5 V, 2034-202 | 2034-202 / 2034-202 | 04045396130487 | — | On the market |
Similar devices
Other devices filed under FDA product code ERA (Otoscope).
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- OPTUS OTOSCOPES by Optus, Inc.
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- OTOSCOPE by Truphatek, Ltd.
- BETA 400 LED F.O. OTOSCOPE 2,5 V B-001.11.401 by Heine Optotechnik GmbH & Co. KG